Catheter devices and methods for making them

ABSTRACT

Tubular devices are provided that include a proximal end, a distal end sized for introduction into a patient&#39;s body, a central lumen, a conductor extending between the proximal and distal ends adjacent the central lumen, reinforcement members including windings extending helically around the central lumen, and an outer jacket. The tubular device includes a first portion in which the conductor extends helically around the central lumen, and a second portion in which the conductor extends longitudinally and either a) all of the windings surround the central lumen and the conductor remains outside the windings, b) at least some of the windings pass between the central lumen and the conductor and at least some of the windings surround both the central lumen and the conductor, and c) all of the windings surround both the central lumen and the conductor. Methods for making such tubular devices are also provided.

RELATED APPLICATION DATA

This application is a continuation of co-pending application Ser. No.16/011,398, filed Jun. 18, 2018, and issuing as U.S. Pat. No.11,305,092, which is a continuation of Ser. No. 14/932,763, filed Nov.4, 2015, now U.S. Pat. No. 9,999,745, which claims benefit ofprovisional applications Ser. Nos. 62/075,755, filed Nov. 5, 2014, and62/137,817, filed Mar. 25, 2015, the entire disclosures of which areexpressly incorporated by reference herein.

FIELD OF THE INVENTION

The present invention relates generally to reinforced catheters,sheaths, or other tubular devices including multiple lumens, and, moreparticularly, to catheters, sheaths, or other tubular devices includingwires or other conductors braided or otherwise incorporated into thetubular devices, e.g., for electrodes, sensing elements, and/or otherelectrical elements carried by the tubular devices, and to methods formaking such tubular devices.

BACKGROUND

Elongate tubular devices, such as diagnostic or treatment catheters orsheaths may be provided for introduction into a patient's body, e.g.,the patient's vasculature or other body lumens. For example, a cathetermay have a distal portion configured to be introduced into a body lumenand advanced to one or more desired locations within the patient's bodyby manipulating a proximal end of the catheter.

To facilitate introduction of such a catheter, one or more wires,cables, or other steering elements may be provided within the catheter,e.g., that are coupled to the distal portion and may be pulled oradvanced from the proximal end to deflect the distal portion. Forexample, a steering element may be provided that is intended to deflectthe distal portion within a predetermined plane and/or into a desiredcurved shape.

Pull wires are a common way to impart deflection ability to such acatheter. However, there are a number of drawbacks associated with suchpull wires. For example, a pull wire occupies a significant amount ofspace within the catheter body. In addition, a pull wire frequentlyneeds to be reinforced, e.g., on the inside and outside of the braid orother reinforcement of the catheter, e.g., to prevent “pull through”when the pull wire is actuated by pushing or pulling, i.e., theresulting bending moment may cause the pull wire to separate layers ofor tear at least partially through the wall of catheter, potentiallysplitting the catheter. Further, a pull wire can make the torqueproperties of the catheter non-homogenous, making it difficult orimpossible to torque the catheter when the pull wire is actuated, e.g.,within a tortuous pathway. Further, auxiliary lumens, in particularthose located in the wall of a large bore sheath, are difficult tomanufacture with consistency due to difficulties with alignment, handassembly, and the like.

In addition, catheters, sheaths, or other tubular devices may includeone or more wires or conductors therein, e.g., for operating one or moreelements on a distal portion of the device. Incorporating electricallyconductive wires or elements into thin walled tubular devices, such asdeflectable sheaths, may be challenging. For example, one or more wiresmay be provided inside the wall of a catheter that extendlongitudinally, but such wires may add undesired profile to the device.Even more problematic, when a catheter flexes or torques during standardcatheter use, the catheter wall, of necessity, must accommodate the pathlength differences induced by the different arc lengths of the insideand outside bend radii of the catheter, which leads to both compressionand elongation of the wall. During compression, the wire(s) may buckleand subsequently fatigue and/or wear their insulation, while duringextension, the wire(s) and any associated insulation may not be able tohandle the required elongation without compromising the wire(s) or theirinsulation. In the case of a wire conductor, the conductor may neckafter bending, which may create hot spots, impedance problems, and thelike or eventually fatigue and break, e.g., after bending the cathetermultiple times as it is manipulated within a patient's body. Changes toelectrical properties in any way may be problematic as the conductorsare used for many purposes including impedance measurements, highcurrent delivery (e.g., RF ablation), high voltage delivery (e.g.,defibrillation), simple tissue voltage/timing measurements, and thelike.

Accordingly, there is a need for improved catheters, sheaths, and othertubular devices and methods of their manufacture.

SUMMARY

The present invention is directed to reinforced catheters, sheaths, orother tubular devices including one or more lumens. More particularly,the present invention is directed to catheters, sheaths, or othertubular devices including wires or other conductors braided or otherwiseincorporated into the tubular devices, e.g., for electrodes, sensingelements, imaging elements, therapeutic elements, and/or otherelectrical elements carried by the tubular devices, and to methods formaking such tubular devices.

In accordance with one embodiment, a tubular device is provided for acatheter or sheath that includes a proximal end, a distal end sized forintroduction into a patient's body, a central lumen extending betweenthe proximal and distal ends, thereby defining a longitudinal axis, anelongate conductor extending at least partially between the proximal anddistal ends adjacent the central lumen, one or more reinforcementmembers comprising windings extending helically around the central lumenbetween the proximal and distal ends, and an outer jacket surroundingthe one or more reinforcement members. In addition, the tubular devicemay include a first portion in which the conductor extends helicallyaround the central lumen, and a second portion in which the conductorextends substantially parallel to the longitudinal axis and either a)all of the windings surround the central lumen and the conductor remainsoutside the windings, b) at least some of the windings pass between thecentral lumen and the conductor and at least some of the windingssurround both the central lumen and the conductor, or c) all of thewindings surround both the central lumen and the conductor.

In accordance with another embodiment, a tubular device is provided fora catheter or sheath that includes a proximal end, a distal end sizedfor introduction into a patient's body, a central lumen extendingbetween the proximal and distal ends, thereby defining a longitudinalaxis, one or more reinforcement members comprising windings extendinghelically around the central lumen between the proximal and distal ends,an outer jacket surrounding the one or more reinforcement members, aconductor extending at least partially between the proximal and distalends adjacent the central lumen, and a steering element extendingbetween the proximal and distal ends within an auxiliary lumen. Thetubular device may also include a steerable distal portion adjacent thedistal end in which the conductor and steering element extendsubstantially parallel to the longitudinal axis with the auxiliary lumenoffset about ninety degrees around a circumference of the distal portionrelative to the conductor, and an intermediate portion proximal to thedistal portion in which the conductor extends helically around thecentral lumen and is braided with the reinforcement members.

In accordance with still another embodiment, a tubular device isprovided for a catheter or sheath that includes a proximal end, a distalend sized for introduction into a patient's body, a central lumenextending between the proximal and distal ends, thereby defining alongitudinal axis, one or more reinforcement members comprising windingsextending helically around the central lumen between the proximal anddistal ends, an outer jacket surrounding the one or more reinforcementmembers, and a plurality of conductors extending at least partiallybetween the proximal and distal ends adjacent the central lumen. Thetubular device may also include a distal portion adjacent the distal endincluding a plurality of sensing elements spaced apart from one anotheralong the distal portion, each sensing element coupled to at least oneof the conductors, and an intermediate portion proximal to the distalportion in which the conductors extend helically around the centrallumen and are braided with the reinforcement members.

In accordance with another embodiment, a method is provided for making atubular body that includes directing a primary mandrel along a centralaxis of a braiding apparatus such that the primary mandrel is surroundedby a plurality of reinforcement carrying elements in a predeterminedconfiguration relative to the central axis, and providing an elongateconductor dispenser at a first location adjacent to the reinforcementcarrying elements and offset from the central axis. With a conductorfeeding from the dispenser at the first location, reinforcement membersfrom the reinforcement carrying elements and the conductor from thedispenser are simultaneously wrapping helically around a first portionof the primary mandrel.

The dispenser is moved to a second location, and, with the conductorfeeding from the dispenser at the second location, reinforcement membersfrom the reinforcement carrying elements are wrapped helically around asecond portion of the primary mandrel while the conductor extendssubstantially axially along the second portion. Optionally, an outerjacket may be applied around the primary and secondary mandrels afterwrapping the one or more reinforcement members therearound, and/or theprimary mandrel may be removed to define a primary lumen within thetubular body.

In accordance with yet another embodiment, a method is provided formaking a tubular body that includes directing a primary mandrel along acentral axis of a braiding apparatus such that the primary mandrel issurrounded by a plurality of reinforcement carrying elements in apredetermined configuration relative to the central axis; providing anelongate conductor dispenser at a first location adjacent to thereinforcement carrying elements and offset from the central axis; with aconductor feeding from the dispenser at the first location,simultaneously wrapping reinforcement members from the reinforcementcarrying elements and wrapping the conductor from the dispenserhelically around a first portion of the primary mandrel; moving thedispenser to a second location; with the conductor feeding from thedispenser at the second location, wrapping reinforcement members fromthe reinforcement carrying elements helically around a second portion ofthe primary mandrel such that the conductor remains outside thereinforcement members; applying an outer jacket around the primary andsecondary mandrels after wrapping the one or more reinforcement memberstherearound; and removing the primary mandrel to define a primary lumenwithin the tubular body.

In accordance with still another embodiments, a method is provided formaking a tubular body that includes directing a primary mandrel along acentral axis of a braiding apparatus such that the primary mandrel issurrounded by a plurality of reinforcement carrying elements in apredetermined configuration relative to the central axis; providing anelongate member dispenser at a first location adjacent to thereinforcement carrying elements and offset from the central axis; withan elongate member feeding from the dispenser at the first location,simultaneously wrapping reinforcement members from the reinforcementcarrying elements and wrapping the elongate member from the dispenserhelically around a first portion of the primary mandrel; moving thedispenser to a second location; with the elongate member feeding fromthe dispenser at the second location, wrapping reinforcement membersfrom the reinforcement carrying elements helically around a secondportion of the primary mandrel while the elongate member extendssubstantially axially along the second portion; applying an outer jacketaround the primary and secondary mandrels after wrapping the one or morereinforcement members therearound; and removing the primary mandrel todefine a primary lumen within the tubular body. In exemplaryembodiments, the elongate member may include one of a conductor, afiberoptic bundle, a tensile element, and a stiffening element.

In accordance with another embodiment, a method is provided for making atubular body using a braiding apparatus comprising a primary mandrelsource configured to direct a primary mandrel along a central axis, aplurality of horn gears movably mounted around the central axis in apredetermined arrangement such that the horn gears rotate aboutrespective horn gear axes and carriers travel along a generally circularpath around the central axis during operation of the braiding apparatus,and a dispenser configured to direct a conductor towards the primarymandrel from one of a plurality of locations comprising a first locationdisposed adjacent one of the carriers, a second location aligned with ahorn axis of one of the horn gears, a third location outside thegenerally circular path, and a fourth location adjacent the central axiswithin the generally circular path.

The method generally includes braiding a first portion of the primarymandrel by: a) directing the primary mandrel along the central axis; b)providing the dispenser at one of the plurality of locations; c)directing the conductor from the dispenser towards the primary mandrelsuch that the dispenser is disposed adjacent the first portion of theprimary mandrel in a first configuration; and d) wrapping reinforcementmembers from the horn gears around the first portion of the primarymandrel. The method may also include braiding a second portion of theprimary mandrel by: a) moving the dispenser to another of the pluralityof locations; b) directing the primary mandrel further along the centralaxis; and c) directing the conductor from the dispenser towards theprimary mandrel such that the dispenser is disposed adjacent the firstportion of the primary mandrel in a second configuration different thanthe first configuration; d) wrapping reinforcement members from the horngears around the second portion of the primary mandrel. Optionally, anouter jacket may be applied around the first and second portions of theprimary mandrel and the secondary mandrel, and/or the primary mandrelmay be removed to define a primary lumen within the tubular body.

Other aspects and features of the present invention will become apparentfrom consideration of the following description taken in conjunctionwith the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings illustrate exemplary embodiments of the invention, inwhich:

FIG. 1A is a perspective view of an exemplary embodiment of a catheter,including multiple lumens extending between proximal and distal endsthereof, and including a steerable distal portion.

FIG. 1B is a cross-sectional side view of the catheter of FIG. 1A, takenalong line 1B-1B, showing reinforcement members positioned aroundprimary and auxiliary lumens of the catheter.

FIGS. 2A and 2B are top and side views, respectively, of an exemplaryembodiment of a catheter including an elongate wire helically braidedalong an intermediate portion of the catheter and extendingsubstantially axially along a distal portion of the catheter.

FIG. 3A is a detail of a distal portion of an exemplary embodiment of anassembly for a tubular device including a plurality of electrodes andwires incorporated into a reinforcing layer of the assembly.

FIG. 3B is a detail of a proximal portion of an exemplary embodiment ofan assembly for a tubular device including a plurality of wiresincorporated into a reinforcing layer of the assembly and exiting theassembly.

FIG. 4A is a schematic of an exemplary embodiment of a braidingapparatus for making a reinforced tubular member including multiplemandrels supported by reinforcement members.

FIG. 4B is a front view of an arrangement of horn gears for creating abraided configuration of reinforcement members that may be included inthe braiding apparatus of FIG. 4A and including various locations fordispensers carrying conductors.

FIG. 4C is a cross-sectional view of a catheter showing the locations ofa conductor corresponding to different locations for the conductordispensers shown in FIG. 4B.

FIGS. 5A and 5B show exemplary embodiments of conductor dispensers thatmay be included in the braiding apparatus of FIGS. 4A and 4B.

FIGS. 6A-6C are details showing exemplary embodiments of electrodecomponents that may be included in a tubular device.

FIGS. 7A and 7B are details showing exemplary configurations forincorporating conductors into a tubular device.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

Turning to the drawings, FIGS. 1A and 1B show an exemplary embodiment ofan apparatus 10 for introduction into a body lumen (not shown), e.g.,for performing a diagnostic and/or therapeutic procedure within apatient's body. In exemplary embodiments, the apparatus 10 may be aguide catheter, a sheath, a procedure catheter, e.g., an imagingcatheter, an ablation and/or mapping catheter, a balloon catheter, orother tubular device sized for introduction into a body lumen, such as avessel within a patient's vasculature, a passage within a patient'sgastrointestinal tract, urogenital tract, reproductive tract,respiratory tract, lymphatic system, and the like (not shown). Inexemplary embodiments, the apparatus 10 may have a length between aboutten and one hundred thirty centimeters (10-130 cm), and an outerdiameter between about four and twenty-four French (4-24 Fr or 1.33-8.0mm).

Generally, the apparatus 10 is an elongate tubular member including aproximal end 12, a distal end 14 sized for insertion into a body lumenor other location within a patient's body, a central longitudinal axis16 extending between the proximal and distal ends 12, 14, and one ormore lumens 18 extending between the proximal and distal ends 12, 14.For example, as shown in FIG. 1B, the apparatus 10 may include a centralor primary lumen 18 a, e.g., sized for receiving or carrying one or moreinstruments or other elements (not shown). In exemplary embodiments, thecentral lumen 18 a may be sized for receiving or carrying a guide wire,procedure catheter, balloon catheter, ablation catheter, cardiac lead,needle, or other instrument (not shown), one or more wires or otherconductors, one or more optical fibers, one or more tubes or accessorylumens, one or more mechanical elements, one or more sensors, and/orsized for delivering and/or removing fluids or other flowable agents ormaterials therethrough.

In one embodiment, shown in FIG. 1A, the central lumen 18 a may exit ator communicate with an outlet 17 in the distal end 14, e.g., to allow aguidewire or other instrument (not shown) to pass therethrough and/orfor delivering or aspirating fluid therethrough. Alternatively, thecentral lumen 18 a may be enclosed, e.g., terminating within or adjacentthe distal end, e.g., by an electrode, cap, or other component (notshown) to isolate the central lumen 18 a and/or elements carried thereinfrom the environment outside the apparatus 10.

Returning to FIG. 1B, optionally, in addition to the central lumen 18 a,the apparatus 10 may include an auxiliary lumen 18 b, e.g., extendingadjacent the central lumen 18 a, e.g., substantially parallel to andradially offset relative to the central axis 16. For example, in anexemplary embodiment, the auxiliary lumen 18 b may be a steering elementlumen configured to receive a pull wire or other steering element (notshown) therein, e.g., to bend or otherwise deflect a distal portion ofthe catheter 10, as described further elsewhere herein.

With continued reference to FIGS. 1A and 1B, optionally, the apparatus10 may include one or more additional lumens (not shown), e.g., one ormore additional steering element lumens, conductor lumens, inflationlumens (e.g., if the apparatus 10 includes one or more balloons, notshown on the distal end 14), and/or accessory lumens. For example, apair of auxiliary lumens may be provided (not shown) on opposite sidesof the apparatus 10, e.g., offset about one hundred eight degrees (180°)around the circumference of the apparatus 10 from one another, e.g., forreceiving respective steering elements.

Optionally, the auxiliary lumen(s) may have a variety of cross-sectionalshapes and/or sizes, e.g., a substantially circular shape, an ellipticalor oval shape, a substantially rectangular shape, a triangular shape, apair of overlapping circles shape, and the like, e.g., similar to thedevices disclosed in U.S. Publication No. 2014/0323964, the entiredisclosure of which is expressly incorporated by reference herein. Theshape and/or size of the auxiliary lumen(s) may be substantially uniformalong the length of the apparatus 10 or may vary at different locations,as described elsewhere herein.

The auxiliary lumen 18 b is generally radially offset from the centralaxis 16 substantially along the length of the apparatus 10, e.g.,entirely from the distal end 14 to the proximal end 12. In addition, theradial and/or circumferential position of the auxiliary lumen 18 b maychange relative to the primary lumen 18 a and/or other components of theapparatus 10 at various locations along the length of the apparatus 10,as described elsewhere herein and in the references incorporated byreference herein.

Returning to FIG. 1A, the distal end 14 may include a tapered, rounded,or otherwise shaped distal tip 15, e.g., to provide a substantiallyatraumatic tip and/or to facilitate advancement or navigation throughvarious anatomy. In addition or alternatively, the distal end 14 mayinclude one or more therapeutic and/or diagnostic elements, e.g., one ormore balloons, stents, sensors, electrodes, ablation elements,thermocouples, steering mechanisms, imaging devices, helical anchors,needles, and the like (not shown), depending upon the particularintended application for the apparatus 10. Further, in addition oralternatively, the distal end 14 may include one or more markers orother features to enhance radiopacity and/or visibility underultrasound, MRI or other imaging modalities, e.g., by mounting one ormore platinum elements on the distal end 14, doping one or more regionsof the distal end 14 with tungsten or barium sulfate, and/or othermethods known in the art.

Optionally, as shown in FIG. 1A, the proximal end 12 may include ahandle or hub 30, e.g., configured and/or sized for holding and/ormanipulating the apparatus 10 from the proximal end 12. In addition, thehandle 30 may include one or more ports, e.g., port 32 a communicatingwith the central lumen 18 a, or other respective lumens (not shown).Optionally, the port 32 a may include one or more valves, e.g., ahemostatic valve (also not shown), which may provide a substantiallyfluid-tight seal, while accommodating insertion of one or moreinstruments or fluids into the central lumen 18 a. Optionally, a sideport (not shown) may be provided on the handle 30, e.g., for deliveringfluid into and/or aspirating fluid from the primary lumen 18 a, e.g.,around an instrument inserted into the primary lumen 18 a. Optionally,the handle 30 and/or proximal end 12 may include one or more connectors,such as luer lock connectors, electrical connectors, and the like, forconnecting other devices (not shown) to the apparatus 10, such assyringes, displays, controllers, and the like (also not shown).

In addition, the handle 30 may include one or more actuators, such assliders, buttons, switches, rotational actuators, and the like, e.g.,for activating and/or manipulating components (also not shown) on thedistal end 14 or otherwise operating the apparatus 10. For example, asshown in FIG. 1A, an actuator 34 may be provided that is coupled to aproximal end of a steering element (not shown) within the auxiliarylumen 18 b, e.g., as described further elsewhere herein.

Generally, with particular reference to FIG. 1B, the apparatus 10 mayinclude an inner liner 40, e.g., at least partially or entirelysurrounding or otherwise defining the central lumen 18 a, areinforcement layer 42 surrounding the inner liner 40, and an outerjacket 44 surrounding and/or encasing the reinforcement layer 42, eachof which may extend at least partially between the proximal and distalends 12, 14 of the apparatus 10. The reinforcement layer 42 and/or outerjacket 44 may be attached to the inner liner 40, e.g., by laminating,adhering, adhesive bonding, ultrasonic welding, reflowing or otherheating, and the like, as described elsewhere herein.

In an exemplary embodiment, the central lumen 18 a is defined by aninner liner 40 a including an inner surface 41 a. The inner liner 40 amay be formed from lubricious material, e.g., PTFE, to provide alubricious inner surface 41 a. Alternatively, the inner liner 40 may beformed from one or more layers of thermoplastic or other polymericmaterial including one or more coatings on the inner surface 41 a havingdesired properties, e.g., a hydrophilic and/or lubricious coating, e.g.,similar to the liners disclosed in U.S. Pat. Nos. 7,550,053 and7,553,387, and U.S. Publication No. 2009/0126862, the disclosures ofwhich are expressly incorporated by reference herein.

Optionally, as shown in FIG. 1B, an inner liner 40 b may also at leastpartially surround the auxiliary lumen 18 b, which may be formed from alubricious material and/or may include one or more coatings on its innersurface 41 b, similar to the inner liner 40 a. The inner surface 41 b ofthe auxiliary lumen 18 b may have a substantially uniform cross-section,as shown in FIG. 1B. Alternatively, the inner surface 41 b of theauxiliary lumen 18 b may have a textured or other variable cross-sectionalong, e.g., along its length and/or about its circumference (notshown).

Optionally, any or all of the inner liner 40 a, reinforcement layer 42,and/or outer jacket 44 may be formed from multiple layers of like ordifferent materials (not shown), e.g., to provide desired materialproperties in the different portions of the apparatus 10. In anexemplary embodiment, the outer jacket 44 may be formed from PEBAX,nylon, urethane, and/or other thermoplastic material, e.g., such thatthe material of the outer jacket 44 may be heated and reflowed and/orotherwise formed around the components defining the lumens 18, e.g., asdescribed elsewhere herein.

In one embodiment, one or more of the layers of the apparatus 10 mayhave a substantially homogenous construction between the proximal anddistal ends 12, 14. Alternatively, the construction may vary along thelength of the apparatus 10 to provide desired properties, e.g., betweenproximal, intermediate, and distal portions 20, 22, 24. For example, aproximal portion 20 of the apparatus 10 adjacent the proximal end 12 maybe substantially rigid or semi-rigid, e.g., providing sufficient columnstrength to allow the distal end 14 of the apparatus 10 to be pushed orotherwise manipulated from the proximal end 12, while the distal portion24 may be substantially flexible. As described further below, the distalportion 24 of the apparatus 10 may be steerable, i.e., may be bent,curved, or otherwise deflected in a desired manner, e.g., substantiallywithin a steering plane, as described further below.

Returning to FIG. 1B, the reinforcement layer 42 may include one or morereinforcement members 43, e.g., wound in a braided or other helicalconfiguration around the inner liner 40 a, e.g., using a braidingapparatus such as that shown in FIGS. 4A and 4B, and the outer jacket 44may include one or more tubular layers surrounding the reinforcementlayer 42 and/or between the reinforcement layer 42 and the inner liner40 a. In an exemplary embodiment, the reinforcement layer 42 may includeone or more, or a plurality of, round or flat (e.g., rectangular,elliptical, or flat oval) wires, filaments, strands, or otherreinforcement members 43, e.g., formed from metal, such as stainlesssteel, plastic, such as PEEK, glass, woven or twisted fibers, such asaramid, and the like, or composite materials.

In one embodiment, a plurality of reinforcement members 43 may bebraided around the inner liner 40 a, e.g., with each reinforcementmember 43 having the same material and/or shape. Alternatively, thereinforcement members 43 may have different sizes and/or shapes, e.g., afirst size or shape extending helically in a first direction and asecond size or shape (different than the first) extending helically in asecond direction (e.g., opposite the first direction).

The reinforcement layer 42 may be configured to substantially transfertorsional forces between the proximal and distal ends 12, 14, e.g., toallow the apparatus 10 to be twisted from the proximal end 12 to rotatethe distal end 14 about the longitudinal axis 16 within a patient'sbody. In addition, the reinforcement layer 42 may allow the distal end14 of the apparatus 10 to be advanced or otherwise manipulated within apatient's body from the proximal end 12 without substantial risk ofbuckling and/or kinking. The pitch of the reinforcement layer 42 may bevaried along the length of the apparatus 10, e.g., in order to optimizemechanical properties of various segments or portions of the apparatus10.

In addition, as shown in FIGS. 2A and 2B, the apparatus 10 may includeone or more elongate wires or conductors 45 extending at least partiallybetween the proximal and distal ends 12, 14. The conductor(s) 45 may becoupled to one or more electrodes, sensors, imaging devices, actuators,therapeutic elements, and/or other electrical components on theapparatus 10, e.g., a plurality of electrodes or sensors spaced apartfrom one another on the distal portion 24 of the apparatus 10 (oneexemplary electrode 48 shown in FIGS. 2A and 2B).

In exemplary embodiments, the conductor(s) 45 may include a metal orother conductive core encased in insulation, e.g., to electricallyisolate the conductor(s) 45 from the reinforcement members 43 and/orother components of the apparatus 10. Exemplary materials for theconductor(s) 45 and/or electrodes 48 may include platinum and/orplatinum alloys (e.g., including iridium, and the like), gold, and/orother precious metals and/or highly conductive metals and/or otherconductive materials (e.g., carbon elements, stainless steel). Furtheralternatives may include wire having a silver core and cobalt chromiumalloy jacket, e.g., a highly conductive core with an outer layer formechanical strength. Conductors may include an electrical insulationlayer and/or coating, which in certain cases may also improve mechanicalproperties, e.g., PTFE, FEP, polyimide, silicone, parylenes, etc.Plating of gold, platinum, and/or other desirable materials may also beused for the electrodes 48.

The location of the conductor(s) 45 may vary relative to the centrallumen 18 a and/or the reinforcement layer 42 (not shown in FIGS. 2A and2B, see, e.g., FIG. 1B) along different portions of the apparatus 10.For example, along a first portion, e.g., the intermediate portion 22shown in FIGS. 2A and 2B, the conductor(s) 45 may extend helicallyaround the central lumen 18 a, e.g., braided along with thereinforcement members 43, as shown in FIG. 1B. Along a second portion,e.g., the distal portion 24 shown in FIGS. 2A and 2B, the conductor(s)45 may extend substantially longitudinally or axially relative to thecentral lumen 18 a, which may facilitate coupling the conductor(s) 45 toone or more electrodes or sensors, e.g., electrode 48.

In addition or alternatively, the location of the conductor(s) 45 mayvary relative to the outer jacket 44 and/or reinforcement layer 42. Forexample, the conductor(s) 45 may be braided along with the reinforcementmembers 43 along a first portion, e.g., the intermediate portion 22,while along a second portion, e.g., the distal portion 24, theconductor(s) 45 may be disposed outside the reinforcement layer 42,e.g., which may facilitate accessing the conductor(s) 45 through theouter jacket 44 during fabrication, as described elsewhere herein.Alternatively, the conductor(s) 45 may be captured within thereinforcement layer 42 or surrounded by the reinforcement layer 42 whileextending longitudinally, as described further elsewhere herein.

Optionally, as shown in FIGS. 2A and 2B, the distal portion 24 of theapparatus 10 may be steerable or deflectable, e.g., using one or morepull wires, cables, fibers, threads, filaments, or other steeringelements, such as a pull wire 36 slidably received within auxiliarylumen 18 b. The steering element 36 generally includes a proximal end(not shown) coupled to an actuator, e.g., such as the actuator 34 on thehandle 30 shown in FIG. 1A, and extends from a proximal portion (notshown) through the intermediate portion 22 and into the distal portion24. A distal end 36 b of the steering element 36 may be fixed orotherwise coupled to the distal end 14, e.g., to a ring or othercomponent (not shown) defining or adjacent the distal tip 15.

The steering element 36 may be formed from materials capable ofsubstantially transferring any axial forces applied at the proximal end12 to the distal end 14, as is known in the art. Optionally, thesteering element 36 may include a coating, e.g., PTFE, parylene,silicone, or other lubricious material, an outer sleeve, e.g., formedfrom HDPE, PTFE, and the like, to reduce friction between the steeringelement and the wall of the auxiliary lumen 18 b. Alternatively or inaddition, the inner surface of the auxiliary lumen 18 b may be formedfrom lubricious material and/or may include one or more coatings, asdescribed elsewhere herein. Alternatively or in addition, the auxiliarylumen 18 b may include one or more incompressible elements, e.g., atightly wound coil therearound, e.g., to prevent compression, which mayotherwise lead to creating a bending moment along at least part of itslength.

During use, the actuator may be activated, e.g., directed proximally ordistally relative to the handle and/or the proximal end (not shown), toapply an axial force to the steering element 36, e.g., tension (when thesteering element is pulled) or compression (when the steering element isadvanced). Because the steering element 36 is slidable within theauxiliary lumen 18 b, the axial force is translated and applied to thedistal end 36 b coupled to the distal end 14. Further, because theauxiliary lumen 18 b is offset from the central axis 16 along at leastthe distal portion 24, the axial force applies a bending moment, therebycausing the distal portion 24 to curve, bend, or otherwise deflect in adesired plane or other manner (e.g., as shown in phantom in FIG. 2B).Optionally, the proximal and intermediate portions 20, 22 of theapparatus 10 may be constructed to prevent or minimize bending forcescaused by actuation of the steering element 36.

Optionally, in the configuration shown in FIGS. 2A and 2B, along thedistal portion 24, a distal segment of the auxiliary lumen 18 b may besurrounded by the reinforcement layer 42 (not shown), e.g., immediatelyadjacent the central lumen 18 a, and then may transition such that anintermediate segment of the auxiliary lumen 18 b is outside thereinforcement layer 42, e.g., closer to an outer surface of theapparatus 10 along at least the intermediate portion 22 (and/oroptionally along the proximal portion 20 to the proximal end 12 and/orhandle 30, not shown; see FIG. 1A). Alternatively, the intermediatesegment may be braided into the reinforcement layer 42.

One potential advantage of the apparatus 10 is that the conductor 45 maybe offset around the circumference of the distal portion 24 relative tothe auxiliary lumen 18 b, e.g., about ninety degrees (90°). Thus, theconductor 45 may be offset about ninety degrees outside the plane ofcurvature or deflection (e.g., within the plane of FIG. 2B) such thatcompression and/or extension of the conductor 45 is minimized. Incontrast, if the conductor 45 were positioned axially adjacent theauxiliary lumen 18 b, the conductor 45 would be compressed when thedistal portion 24 was deflected towards the side including the conductor45 and extended when the distal portion 24 was deflected in the oppositedirection within the plane. Such compression and/or extension of theconductor 45 may risk damage to the conductor 45, as explained elsewhereherein. Another potential advantage is that the conductor 45 may bepositioned outside the plane of deflection and therefore may not resistbending of the distal portion 24 within the plane.

Turning to FIGS. 3A and 3B, in another embodiment, an apparatus 110 maybe provided that includes a plurality of sensors, actuators, electrodes,imaging elements, and/or or other components 148 on a distal portion 124of the apparatus 110, which may be coupled to one or more wires orconductors 145 extending helically and proximally from the distalportion 124 (shown in FIG. 3A), e.g., through an intermediate portion122 to a proximal portion 120 (shown in FIG. 3B), and the conductors 145may be coupled to one or more connectors and/or electronics at theproximal end (not shown) of the final apparatus 110.

In the exemplary embodiment shown, the conductors 145 may be braidedinto the reinforcement layer 142, e.g., at least along the intermediateportion 122, such that the conductors 145 extend helically in the samedirection adjacent one another. Optionally, the conductors 145 may bedisposed immediately adjacent one another, e.g., such that there are noreinforcement members 143 between the conductors 145. Alternatively, theconductors 145 may be positioned immediately adjacent to a reinforcementmember 143, e.g., as shown in FIG. 3B, which may enhance protection ofthe conductors 145. For example, during the braiding process, anycontact by other reinforcement members 143 being braided around theapparatus 110 may be directed to the adjacent reinforcement members 143,which may protect the insulation and/or minimize abrasion or undesiredcontact with the conductors 145, e.g., if at least one adjacentreinforcement member 143 is larger in diameter or other cross-sectionthan the conductor 145.

Optionally, the conductors 145 may transition to positions outside thereinforcement layer 142, e.g., at one or more axial locations on theproximal portion 120, e.g., for a relatively short distance. Thisposition may facilitate accessing free ends 145 a of the conductors 145,e.g., to couple the conductors 145 to components within a handle (notshown) of the final apparatus 110 and/or to form and/or modify theexposed conductor, e.g., to form an electrode. Alternatively, theconductors 145 may simply exit an outer jacket (not shown) of the finalapparatus 110 at one or more locations along the proximal portion 120.For example, as shown, the conductors 145 may exit at locations spacedapart from one another. Alternatively, the conductors 145 may exit atthe same axial location, e.g., at different positions around thecircumference of the proximal portion 120 (not shown).

Turning to FIGS. 4A-4C, various methods may be used for manufacturingand/or assembling any of the embodiments described herein. For example,FIG. 4A shows an exemplary embodiment of an apparatus 50 for making oneor more tubular bodies, such as catheters and/or components forcatheters, sheaths, or other tubular devices 8. Generally, the apparatus50 includes one or more plurality of sources 52, 54 of mandrels 2 and/orliners 4, a guide 60, one or more dispensers or other sources ofconductors 56, a source 70 of reinforcement members 6, a drive mechanism80, and, optionally, a source 90 of jacket material 7.

While mandrels, liners, and/or jackets may be provided in discretesegments (not shown), the apparatus 50 may allow for substantiallycontinuous fabrication of tubular bodies, e.g., wrapping a linermaterial 4 a around a primary mandrel 2 a (or the primary mandrel 2 amay include a tubular or other liner material provided around it on thesource 52, e.g., similar to the liners disclosed in the referencesincorporated by reference elsewhere herein), positioning an auxiliarymandrel 2 b (with optional liner material, not shown) adjacent theprimary mandrel 2 a, braiding a plurality of reinforcement members 4around the mandrels 2, adding one or more conductors 58, and optionally,applying outer jacket material 7 around the reinforced mandrels, asdescribed further below.

As used herein, “substantially continuous” means that the apparatus 50and/or method may operate indefinitely, i.e., to make as few as one oras many as hundreds or thousands of tubular bodies 8, e.g., bysubstantially simultaneously feeding components of the tubular bodies 8from sources 52, such as reels, through components of the apparatus 50until the sources 52 are depleted, whereupon new source(s) may be loadedonto the apparatus 50 and the process continued. Alternatively, theapparatus 50 may be used to create discrete lengths of tubular devices,e.g., if the mandrels and/or liners are provided in specific lengthscorresponding to one or more individual tubular devices (not shown). Ina further alternative, some of the operations may be performedsubstantially continuously, while other operations are performed oncomponents intended for one or more individual tubular devices.

Thus, the apparatus 50 and methods herein may be used to make one ormore relatively long tubular bodies 8, e.g., that are substantiallylonger than finished catheters or other tubular devices. For example,one resulting tubular body 8 may be collected, e.g., on a take-up reelor container (not shown), or may be separated into individual shortertubular bodies, e.g., using a cutter or other tool (not shown), that maybe incorporated into individual catheters or other tubular devices,e.g., as described elsewhere herein and/or as disclosed in U.S.Publication No. 2009/0126862, the entire disclosure of which isexpressly incorporated by reference herein.

With particular reference to FIG. 4A, the apparatus 50 may include oneor more sources 52 of mandrels 2, which may be fed into a guide 60 todefine lumens of the tubular bodies 8. For example, a first reel 52 amay include an elongate primary mandrel 2 a, e.g., shaped and/orconfigured to define a primary or central lumen (not shown) of thetubular bodies 8. Similarly, a second reel 52 b may include an elongateauxiliary mandrel 2 b, e.g., shaped and/or configured to define asecondary or auxiliary lumen (also not shown) of the tubular bodies 8.As described further below, the second reel 52 b or other source ofauxiliary mandrel may be located at one of a plurality of availablelocations during operation to configure the tubular bodies 8 in adesired manner. Optionally, if additional lumens are desired for thetubular bodies 8, one or more additional auxiliary mandrels may beprovided (not shown), which may also be moved to one or more locations.

The mandrels 2 may have desired cross-sectional shapes and/or sizescorresponding to the desired cross-sections of the lumens, e.g.,substantially circular or other shapes, as described elsewhere herein.The mandrels 2 may be a solid or hollow wire or other cylindrical memberhaving a diameter (or other cross-section) corresponding to the diameterof the lumen to be lined by the strip 24, e.g., between about0.005-0.300 inch (0.125-7.5 mm), 0.014-0.092 inch (0.35-2.3 mm), or0.014-0.045 inch (0.35-1.15 mm). In an exemplary embodiment, theauxiliary mandrel 2 b may have a substantially smaller diameter or othercross-section than the primary mandrel 2 a. In exemplary embodiments,the mandrels 2 may be formed from beading or monofilament material, forexample, lubricious material, e.g., PTFE or other fluoropolymer,silicone-treated Acetal, PTFE-coated stainless steel, Parylene-coatedstainless steel, silver coated copper, and the like, having sufficientflexibility to allow the mandrels 2 to be wound onto a source reel 52and/or onto a take-up reel (not shown) after being incorporated into atubular body 8.

Alternatively or in addition, the mandrels 2 may have a tubular linerpredisposed about them, e.g., a fluoropolymer sleeve or coating or othertubular material which may facilitate removal of the mandrel 2 and/or beleft behind upon removal of the mandrel 2 to form a liner. Furtheralternatively, a shim (not shown) may be positioned over a mandrel 2and/or within a tubular or strip liner such that the shim (not shown)may facilitate creation of a lumen that is larger than the mandrel 2with or without ultimate removal of the mandrel 2. For example, a PTFEtube or strip shim (not shown) may be positioned around a mandrel 2 andinside of a strip or tubular liner. The mandrel/shim/liner assembly maythen be incorporated into a braided shaft or finished apparatus. Theshim (not shown) may be subsequently removed, e.g., after braiding,lamination, etc., to leave a lumen larger than the mandrel. After this,the mandrel may remain in place, for example, in the case of theauxiliary mandrel 2 b to serve as a pull wire, or simply removed withless force.

In an alternative embodiment, the mandrels 2 may be formed from materialthat substantially maintains its size and/or shape during fabrication ofthe tubular bodies, yet may be reduced in cross-section afterfabrication to facilitate removal. For example, silver-coated copperwire, PTFE beading, or other malleable metals or polymers may be usedfor the mandrels 2 that, after fabrication of the tubular body 8, may benecked down before and/or during removal. For example, after fabricatinga tubular body 8, the mandrels 2 (or the entire tubular body) may bepulled at one or both ends, thereby causing the mandrels 2 toplastically elongate and thereby reduce their outer cross-sectionslightly, which may reduce friction between the mandrels 2 and thesurrounding liners, reinforcement members, and/or other materials, andthereby facilitate removal. Further alternatively, the mandrels 2 mayinclude a rolled strip with inherent radial strength capable ofsupporting a lumen during braiding and/or lamination and/or otherprocessing, but may subsequently be constrained, stretched, or otherwiseremoved. Further alternatively, the mandrels 2 may be constructed frommaterial having relatively high thermal expansion such that duringheating, lamination, and/or reflow, the mandrels 2 expand and uponcooling contract, thereby creating a lumen larger than the originalmandrel 2.

In yet another alternative, the mandrels 2 may be formed from materialsthat may be dissolved, e.g., after fabrication, leaving the surroundingmaterials intact to define the lumens.

In still another alternative, tubular mandrels may be used that havesufficient hoop strength to resist deformation under the forcesencountered during braiding and/or other fabrication and/or heating orother processing parameters experienced during fabrication. In thisalternative, the tubular mandrels may remain substantially within thetubular bodies 8 after fabrication, e.g., to define the auxiliary lumen.For example, a relatively thick walled PTFE, a lined or bare polyimidetube, or other tubular mandrel may be used. Alternatively, the innerdiameter of such a tubular mandrel may be temporarily supported by atemporary supporting mandrel (not shown), e.g. during braiding, and thetemporary supporting mandrel may be removed prior to subsequentfabrication and/or heating or other processing steps, e.g., if thetubular mandrel is to remain as a permanent component of the tubularbodies.

Optionally, a source 54 of liner material 4 may be provided for one orboth mandrels 2. For example, as shown, a source 54 a of liner material4 a is provided such that the liner material 4 a may be wrapped at leastpartially around the primary mandrel 2 a, e.g., as the primary mandrel 2a and liner material 4 a are fed through the guide 60. The linermaterial 2 a may be formed from lubricious material and/or may includeone or more coatings (not shown) on an inner surface thereof orientedtowards the primary mandrel 2 a, which may provide an inner liner for aprimary lumen of the resulting tubular bodies 8 a.

For example, the liner material may include a base material, e.g., arelatively thin-walled polymer sheet having a width corresponding to thecircumference of the corresponding mandrel, e.g., thermoplastics, suchas polyether block amide, urethane, nylon, and the like, fluoropolymers,such as PTFE, FEP, TFE, and the like, thermoset, and thermoformplastics, such as polyimide or polyester, and the like. In exemplaryembodiments, the liner material may have a thickness between about0.0001-0.050 inch (0.0025-1.25 mm), 0.0001-0.003 inch (0.0025-0.076 mm),0.0001-0.0015 inch (0.0025-0.038 mm), or 0.0005-0.002 inch (0.0125-0.05mm).

Optionally, if desired a source of liner material may also be providedfor the auxiliary mandrel 2 b and/or for other auxiliary mandrels (notshown for simplicity). In this option, a guide (also not shown) may beprovided for wrapping the liner material around the auxiliary mandrel 2b, e.g., before the auxiliary mandrel 2 b is positioned adjacent theprimary mandrel 2 a. In an alternative embodiment, tubular linermaterial may be provided on one or both mandrels when loaded on thesource 52, and/or may be fed onto the desired mandrel in discretesegments (not shown) before passing the mandrels 2 through the guide 60or horn gear 72.

With additional reference to FIGS. 4A and 4B, the source 70 ofreinforcement members 6 may provide one or more, e.g., a plurality of,reinforcement members 6 that may be wrapped around the mandrels 2, e.g.,upon exiting the guide 60. In the exemplary embodiment shown in FIG. 4B,the reinforcement source 70 may include an arrangement of horn gears 72,e.g., mounted in a generally circular configuration around the guide 60,for example, to a base or other support structure 76. The horn gears 72may be free to rotate about their individual central axes but may besubstantially fixed translationally relative to one another and theguide 60. Alternatively, the horn gears 72 may be rotatable relative tothe guide 60, e.g., around a central axis of the guide 60, e.g., along apath 78 shown in FIG. 4B, while maintaining their same circularconfiguration, e.g., by rotating the base 76 relative to the guide 60,as described further elsewhere herein.

The dispenser(s) 56 may be provided at one or more locations, e.g., tolocate the conductor(s) 58 at one or more positions and/orconfigurations relative to the primary mandrel 2 a and/or thereinforcement members 6. For example, during fabrication, a dispenser 56may be moved to one or more locations to change the position and/orconfiguration of the conductor 58, e.g., to fabricate any of the tubulardevices described elsewhere herein. For example, as shown in FIG. 4B,during operation of the apparatus 50, the dispenser 56 may be positionedat locations A1, A2, A3, and/or A4, e.g., for a predetermined timeand/or distance along the primary mandrel 2 a, and, as desired, moved toone of the other locations one or more times. Thus, in this manner, thelocation of the conductor 58 may be adjusted, e.g., as shown in FIG. 4Cand as described elsewhere herein.

Similarly, the auxiliary mandrel 2 b may be moved to different locationsrelative to the horn gears 72, e.g., to position the auxiliary mandrel 2b relative to the primary mandrel 2 a and/or reinforcement members 6.For example, as shown in FIG. 4B, during operation of the apparatus 50,the source of auxiliary mandrel 2 b may be positioned at locations A1,A2, A3, or A4, e.g., for a predetermined time and/or distance along theprimary mandrel 2 a, and, as desired, moved to one of the otherlocations one or more times. Thus, in this manner, the location of theauxiliary mandrel 2 b may be adjusted, which may result in the locationof an auxiliary lumen defined by the auxiliary mandrel 2 b being movedto desired locations, as shown in FIG. 4C and as described elsewhereherein and in the references incorporated by reference herein.

For example, in the A4 location shown in FIGS. 4A-4C, the dispenser 56may be positioned adjacent a carrier 74 of one of the horn gears 72,e.g., such that the conductor 58 is directed towards the primary mandrel2 a along with or in place of a reinforcement member 6. Thus, at thislocation, as the carrier 74 travels along the generally circular path 78of the horn gears 72, the reinforcement member 6 and conductor 58 mayboth be braided around the primary mandrel 2 a along with the otherreinforcement members 6. From this location, the conductor 58 may bewrapped helically around the primary mandrel 2 a immediately adjacentthe reinforcement member 6, as described elsewhere herein.Alternatively, the dispenser 56 may be carried on the horn gears 72similar to one of the carriers 74, e.g., such that the conductor 58 iswrapped helically around the primary mandrel 2 a independently of theother reinforcement members 6, i.e., is braided around the primarymandrel 2 a, optionally in place of one of the reinforcement members 6.It will be appreciated that a plurality of dispensers and conductors(not shown) may be positioned at the same A4 position or at other A4positions (i.e., adjacent to or in place of one or more carriers) suchthat multiple conductors 58 are wrapped helically around the primarymandrel 2 a, e.g., immediately adjacent one another or spaced apart fromone another in a desired configuration (e.g., in the same helicaldirection with one or more reinforcement members between adjacentconductors, not shown).

If desired, the dispenser(s) 56 may be moved to location A1, i.e., suchthat conductor 58 is delivered along a central axis of one of the horngears 72 a. For example, the horn gear 72 a may include a passage 73 atherethrough, e.g., aligned with the central axis of the horn gear 72 a,and the conductor 58 may pass through the passage 73 a, e.g., from thedispenser 56 towards the primary mandrel 2 a where it exits the guide60. Optionally, if additional conductors are to be provided in thetubular bodies 8, one or more additional horn gears may also includesuch passage(s) and/or guide(s) for guiding corresponding conductor(s)therethrough.

In the A1 location, the conductor 58 may extend substantially axiallyalong the primary mandrel 2 a, yet may be at least partially braidedinto the reinforcement members 6 adjacent the primary mandrel 2 a, i.e.,with some reinforcement members 6 surrounding both the primary mandrel 2a and the auxiliary mandrel 2 b, and some reinforcement members 6surrounding only the primary mandrel 2 a, as identified by conductor A1shown in FIG. 4C. By comparison, in location A2, i.e., with theconductor 58 directed immediately adjacent the primary mandrel 2 a,e.g., through the guide 60, all of the reinforcement members 6 maysurround both the primary mandrel 2 a and the conductor 58, therebypositioning the conductor 58 closest to the primary mandrel 2 a alongthe tubular device 8. Finally, in location A3, i.e., with the dispenser56 and conductor 58 outside the generally circular path of the horngears 72, e.g., outside the path 78 shown in FIG. 4B, or otherwisedirected towards the primary mandrel 2 a after the braiding operation,all of the reinforcement members 6 may only surround the primary mandrel2 a and the conductor 58 may remain outside all of the reinforcementmembers 6, e.g., closest to the outer surface of the tubular device 8shown in FIG. 4C.

Optionally, if desired, individual carriers may be loaded with multiplereinforcement members (not shown), e.g., such that multiplereinforcement members are braided adjacent one another in each directionfrom each carrier. For example, with the conductor 58 directed fromlocation A 1 (also called the “triaxial” location), a first set ofreinforcement members 43 a may travel and be braided in a firstdirection by the horn gears 72 such that all of the windings of thefirst set 43 a pass between the conductor 58 and the primary mandrel 2 aat that specific horn gear. A second set of reinforcement members 43 bmay travel and be braided in a second opposite direction by the horngears 72 such that all of the windings of the second set 43 b pass overthe conductor 58 at that specific horn gear. Otherwise, thereinforcement members may pass over and under one another according tothe arrangement of horn gears 72 and carriers 74 loaded onto thereinforcement source 70, which pattern generally alternates at eachsubsequent horn gear, e.g., as described in U.S. Publication No.2014/0323964, incorporated by reference herein.

With further reference to FIG. 4A, as can be seen, the primary mandrel 2a may exit the guide 60 with the liner material 4 a being wrappedsubstantially around the primary mandrel 2 a. With the conductor 58directed from the desired location, the conductor 58 may be directedtowards the primary mandrel 2 a such that the conductor 58 is braidedaround the primary mandrel 2 a with the reinforcement members 6(location A4), or may extend longitudinally along the primary mandrel 2a and yet be disposed adjacent the primary mandrel 2 a before braiding(location A2), braided into the reinforcement members 6 (location A1),or after braiding (location A3).

At any time, the dispenser 56 may be moved to a different location thanits current one to transition the conductor 58 to the desired positionrelative to the primary mandrel 2 a and/or reinforcement members 6. Thistransition may be performed substantially continuously, e.g., bydirecting the dispenser 56 to the desired location after a predeterminedlength or portion of the tubular device 7 has been braided in thedesired manner. Alternatively, discrete lengths or portions may bebraided in the desired manner, e.g., by stopping the apparatus 50,removing and repositioning the dispenser 56 to position the conductor 58to the desired position relative to the primary mandrel 2 a and/orreinforcement members 6, and then resuming operation for a desired timeand/or length. This process may be repeated as many times as desired,e.g., to produce tubular devices, such as those described elsewhereherein.

Turning to FIGS. 5A and 5B, exemplary embodiments of dispensers 156, 256are shown that may be provided at the desired location(s) relative tothe apparatus 50 of FIGS. 4A and 4B. For example, the dispenser 156shown in FIG. 5A generally includes a housing 160 carrying a spool 162that includes a tension mechanism (not shown), and a guide, e.g., eyelet164, for guiding conductor 158 from the spool 162. Optionally, one ormore additional guides and/or tensioners (not shown) may be provided onthe dispenser 156 and/or between the dispenser 156 and other componentsof the apparatus 50, e.g., to guide the conductor 158 into the desiredposition and/or ensure that the conductor 158 is sufficiently taught asit is directed towards the primary mandrel 2 a.

In addition, the housing 160 may include one or more fasteners,couplings, and/or attachment mechanisms 166 for securing the dispenser156 at a desired location, such as one or more screws, bolts, or otherfasteners, magnets, latches, snap connectors, and the like (not shown).Thus, the dispenser 156 may be mounted at a desired location, conductor158 delivered from the spool 162, and then moved to another location oneor more times, as desired, to position the conductor 158 in the desiredposition and/or configuration relative to the primary mandrel 2 a. Inone embodiment (not shown), the dispenser 156 may mount alongside, e.g.,on the same axle as, a spool carrying one or more reinforcement members6 and may utilize the same tensioning mechanism, guides, etc. orincorporate independent tensioning mechanisms(s), guides, etc.

The length of conductor 158 carried by the dispenser 156 may besufficient for multiple tubular devices, e.g., delivered in asubstantially continuous manner, or for a single tubular device, asdesired. FIG. 5B shows an alternative embodiment of a dispenser 256 thatincludes a housing 260 carrying a spool 262 and guide 264, which may begenerally similar to the dispenser 156. However, in this alternative, anelectrode 259 is included pre-attached on a first or free end of theconductor 258 (with the second end wound on the spool 262). The lengthof the conductor 258 provided on the spool 262 may be sufficient for asingle tubular device, e.g., such that the electrode 259 may be mountedon the primary mandrel (not shown) corresponding to a distal portion ofa tubular device, and then the conductor 258 may be delivered from thespool 262 to position the conductor on or around the primary mandrel, asdesired, e.g., similar to the apparatus 110 shown in FIGS. 3A and 3B.

For example, for the apparatus 110, a conductor 145 may be braidedhelically in a proximal direction from a first (e.g., distal-most)electrode 148 mounted on the reinforcement layer 142. A second electrode148 may be positioned on the reinforcement layer 142 proximal to thefirst electrode 148 and a second conductor 145 braided helically fromthe second electrode 148 (e.g., from another dispenser similar todispenser 256 in FIG. 5B) along with the first conductor 145. Thisprocess may be repeated, as desired, to provide a desired number ofelectrodes 148 and conductors 145, e.g., three as shown in FIGS. 3A and3B.

Once all the desired conductors 145 and electrodes 148 are placed,braiding may be continued proximally, e.g., until the portion of thebraided catheter where the wires either need to exit for attachment toother electrical elements or the catheter is otherwise protected frombending (e.g., which may cause path length changes capable of damaging,fatiguing, breaking, or otherwise affecting the conductors). In anexemplary embodiment, at a desired location corresponding to the desiredexit of each conductor, e.g., adjacent the proximal end, thedispenser(s) may be moved from the A4 (braiding) location to the A3location such that the conductor(s) are placed outside the braid circlefor the remainder of the shaft braiding. In some instances, it may behelpful to have the conductor(s) re-enter the catheter beforetermination at the proximal end whether inside or outside of the hub orhandle. This embodiment may provide one or more advantages, e.g.,relatively low profile, ease of manufacture, protection of theconductor, access to the conductor where needed, flexing of theconductor, providing a braid construction that is substantiallyhomogeneous, and the like as described elsewhere herein.

FIGS. 6A-6C show alternative embodiments of electrodes that may beprovided pre-attached to a conductor and carried by a dispenser, such asthat shown in FIG. 5B. For example, FIG. 6A shows a conductor 258 andelectrode 259 similar to that shown in FIG. 5B, i.e., with a tubularelectrode 259 attached to the conductor 258, e.g., by welding,soldering, fusing, bonding with adhesive, and the like. In analternative embodiment, the electrode(s) may be formed from a portion ofthe conductor itself, e.g., formed into a desired shape or form, e.g.,with desired portion(s) of the conductor removed.

For example, FIG. 6B shows an electrode 259′ in the form of a roundspiral sensor, e.g., formed by coiling an end of the conductor 258′ intoa planar or approximately planar spiral or into a partially cylindricalshape to wrap around a portion of a tubular body. The planar spiralelectrode may be attached over the braid or the outer jacket, asdesired, e.g., by bonding with adhesive, embedding, and the like.

FIG. 6C shows another embodiment electrode 259″ in the form of anannular coil, which may be wrapped or otherwise positioned around theapparatus (not shown). For example, the conductor 258″ may be wrappedone or more times, e.g., multiple times, around a tubular device outsidethe braid, e.g., before or after applying the outer jacket, until a coilof a desired length is formed. In the embodiments of FIGS. 6B and 6C,the insulation may be removed from the outer, exposed surfaces of theresulting coil, e.g., leaving the inner surfaces covered with insulationto avoid electrical contact with reinforcement elements of the braid,which may be conductive or semi-conductive.

Returning to FIGS. 4A and 4B, the drive mechanism 80 may include one ormore components for pulling or otherwise directing the mandrels 2through the apparatus 50. For example, the drive mechanism 80 mayinclude a pair of spaced-apart rollers 82 coupled to a motor (not shown)that engage the reinforcement-wrapped mandrels 2 and apply sufficienttension to pull the mandrels 2 from their sources 52 through the guide60 and/or horn gear 72 a while the reinforcement members 6 are braidedaround the mandrels 2. Alternatively, the drive mechanism may beprovided before the reinforcement members 6 are braided around themandrels 2, e.g., pushing the primary mandrel 2 a through the braidingoperation and potentially pulling the auxiliary mandrel 2 b by thebraiding action itself. Optionally, other drive mechanisms and/ortension adjusters (not shown) may be provided for maintaining a desiredtension and/or otherwise guiding the mandrels 2, liners 4, reinforcementmembers 6, and assembled device in a desired manner along thefabrication path.

Optionally, as shown in FIG. 4A, the jacket source 90 may be providedfor applying one or more layers of jacket material around thereinforcement-wrapped mandrels 2. For example, a co-extruder, laminator,or other applicator may be provided that applies melted, uncured, and/orotherwise raw jacket material 7, e.g., from a hopper or other container(not shown), or rolls sheets of jacket material 7 may be wrapped aroundthe reinforcement members 43 and mandrels 2. For example, forthermoplastic or other flowable materials, a heater (not shown) within aco-extruder may melt or otherwise soften the jacket material 7 to allowthe jacket material 7 to flow around the reinforcement members 43 andinto contact with the liner material 4 surrounding the mandrels 2 (orthe mandrels 2 directly if no liner material is provided).Alternatively, the jacket material 7 may be a thermoset plastic or othermaterial such that components of the jacket material 7 may be deliveredinto the co-extruder, e.g., as a liquid, powder, and the like, and mixedto form a slurry that is delivered around the reinforcement-wrappedmandrels 2. The components may chemically or otherwise react with oneanother and/or be heat fused to form a solid jacket 7 once cured.Exemplary materials for the jacket material 7 include plastics, e.g.,thermoplastics, such as polyether block amide, nylon, or urethanes,thermoset plastics, metals, or composite materials. Alternatively, otherprocessing may be used to bond or otherwise attach the jacket material 7to the liner material 4 and/or embed the reinforcement members 43 in thejacket material 7, thereby resulting in an integral tubular body 8.

The resulting tubular body 8 (with or without jacket material 7) may becollected, e.g., on a capture reel or in a container (not shown).Thereafter, the tubular body 8 may be further processed to make acatheter, sheath, or other device. For example, a cutter or other tool(not shown) may separate the tubular body 8 into individual tubularshafts, e.g., before or after removing the mandrels 2. For example, themandrels 2 may remain within the tubular body 8 when cut into individualdevices, and then may be removed, resulting in a primary lumen, e.g.,similar to the apparatus 10 shown in FIG. 1B. Alternatively, if thefriction between the mandrels 2 and the surrounding material isrelatively low, the mandrels 2 may be removed before the tubular body 8is cut into individual devices.

The resulting inner surface 41 a of the primary lumen 18 a may have asubstantially uniform cross-section, e.g., as shown in FIG. 1B. Similarthe auxiliary lumen 18 b may also have a substantially uniformcross-section, e.g., also as shown in FIG. 1B or may have a variablecross-section, if desired (not shown).

Other components may be added to the individual tubular devices, asdesired for the particular application. For example, for a steerablecatheter, such as the apparatus 10 shown in FIGS. 2A and 2B, a steeringelement 36 may be inserted through the auxiliary lumen 18 b (createdwhen the auxiliary mandrel 2 b is removed). In an alternativeembodiment, the auxiliary mandrel 2 b may remain within the tubulardevice to provide the steering element, e.g., if the friction betweenthe outer surface of the auxiliary mandrel 2 b and the liner or othermaterial defining the auxiliary lumen is relatively low. A tip or othercomponent (not shown) may be attached to a distal end 14 of theapparatus 10, e.g., after attaching the distal end 36 b of the steeringelement 36 to the tip. The other end of the steering element may becoupled to an actuator 34 of a handle 30 attached to a proximal end 12of the apparatus 10, e.g., similar to the embodiment shown in FIG. 1Aand described elsewhere herein.

In alternative embodiments, one or more electrodes may be embeddedwithin the apparatus, rather than electrically exposed on an outersurface of the apparatus. For example, where the primary purpose of theelectrode(s) is to generate or sense an electric or magnetic field (asopposed to a conductive interface necessary for some measurements), theouter jacket may be positioned over the conductors/electrodes (notshown). If the outer jacket is not substantially electricallyconductive, but instead permits the passage of electric or magneticfields, the apparatus may allow transmission and/or sensing of electricor magnetic fields via the embedded electrodes without direct contactwith the tissue.

Such a construction may provide one or more advantages, e.g., in one orboth of construction and performance. For example, with regards toperformance, there may be no chemical interaction between the embeddedelectrode and tissue adjacent the apparatus, which may be used to reducepotential complications or may enable the use of alternative materialsthat might otherwise not be ideal or compatible for its use orinteraction with tissue (for example, a simple copper electrode may beused instead of gold or platinum) since the materials are isolated fromany direct contact with tissue or bodily fluids.

From a construction standpoint, the ability to embed electrodes beneaththe surface of the outer jacket may simplify construction and/or mayenable alternative constructions that make assembly (including variousorders of operations) easier. For example, electrodes are frequentlyattached externally using a number of labor-intensive and sometimescomplicated operations. Sometimes swaging is used to mechanically embedthe electrodes into the wall of the catheter. This embeds the edges ofthe electrode into the jacket making the electrode atraumatic andstable; however it may have a damaging effect on the continuity of thecatheter in terms of inner profile, or torque/kinkresistance/continuity.

In many other instances, the electrodes are bonded to the catheter usingadhesives. In these instances, the same or secondary adhesive is used tocreate a “ramp” or “fillet” to cover the edge of the electrode toprevent it from causing damage to body tissues, etc. In the case ofembedded electrodes, the electrodes may be placed on the catheter beforeapplying the jacket material(s) and/or subsequent lamination. Thelamination of the catheter (a step that is done regardless of thepresence of electrodes) may automatically fix the position of theelectrodes and/or cover the electrode edges, and may do so with minimalimpact to the catheter performance in terms of profile, kink/torqueperformance, and the like.

Embedding the electrode(s) may also simplify the construction andmaintenance of electrical isolation from other electrodes. Theelectrodes may be insulated before or at the time of their placementinto the catheter. For example, an insulator, such as polyimide,parylene, and the like may be used to cover the electrode(s) with athin, insulating barrier such that the electrode(s) cannot beaccidentally placed in electrical connection with other electrodesand/or with other elements of the catheter such as reinforcementmembers, e.g., the electrode inner surface may be electricallyinsulated.

In an alternative embodiment, the embedded electrode(s) may be madeelectrically conductive to the environment outside of the catheter byone or more methods. For example, one or more holes or passages may becut, drilled, laser ablated, achieved by solvent removal, and/orotherwise created through the overlying jacket material to expose atleast a portion of the embedded electrode. Alternatively or in addition,the overlying jacket may be made locally electrically conductive, e.g.,by doping and the like.

Further alternatively, the shape or profile of the embedded electrodemay be such that at least a portion of the embedded electrode isdisposed nearer to, at, or above the surface of the catheter, e.g.,including one or more bumps, knobs, ridges, projections, and the like,e.g., to cause the portion to be exposed during lamination of thecatheter shaft or more easily exposed after lamination of the cathetershaft.

In additional alternative embodiments, in addition to or instead ofwires or conductors, other elongate members may be braided and/orotherwise incorporated into a tubular device, such as one or morefiberoptic bundles, tensile elements, capillary tubing, and/orstiffening elements. For example, a coherent or non-coherent imagingfiber may be provided within a wall of an imaging catheter, illuminationcatheter, and/or other tubular devices that include one or more sensorsof various types (including diffraction gratings for stress strainmeasurements and the associated calibrations for force or position). Theposition and/or configuration, e.g., whether braided or longitudinal,may be selected along one or more portions of the tubular device, asdesired.

Turning to FIG. 7A, in another embodiment, elongate stiffening elementsmay be provided within an apparatus 310 instead of or in addition to oneor more conductors (not shown). For example, as shown, a pair ofstiffening elements 345 may be provided that extend substantiallylongitudinally generally opposite one another along a first portion andthen transition to a helical, braided configuration, e.g., along withone or more reinforcement members 343, as shown. In this embodiment, thestiffening or stabilizing element(s) 345 (e.g., pre-loaded onto adispenser, not shown) may be located at one of the A1, A2, or A3locations in FIGS. 4A-4C, thereby positioning the stiffening element(s)345 substantially longitudinally along one or more portions wherelateral or other stabilization is desired. Outside of such portion(s),where the catheter is desired to again have rotationally homogenousproperties, the stiffening/stabilization element(s) 345 may betransitioned to the A4 location, e.g., braiding along with one or morereinforcement members 343.

For example, two stiffening elements 345 may be provided about onehundred eighty degrees opposite each other, e.g., in the A1 locationalong a strategic portion (for example in a deflectable catheter, or ina shape set catheter). The stiffening elements 345 may resistcompression and/or extension and limit flexing in a single plane. Thisplane may be used for the shape/form setting or the deflection plane,e.g., along a steerable or deflectable distal portion. Proximal to sucha distal portion, another portion of the catheter (e.g., theintermediate and/or proximal portion may become smoothly torqueable bybraiding the stiffening elements 345 substantially helically with thereinforcement members and their stiffening effect may be substantiallyneutralized.

Optionally, more complicated configurations may be provided for elongatecomponents within a tubular device. For example, FIG. 7B shows anexemplary embodiment of an apparatus 410 that includes a plurality ofstiffening elements 445 that are transitioned multiple times between abraided, helical configuration, and a longitudinal configuration. Such arepeated helical/longitudinal construction may provide a tubular devicehaving a desired bend profile, e.g., such that the tubular device bendsin a helical manner, rather than within a plane.

Additionally, the elements may be tensile elements that are otherwiselimp, such as rope, string, braided fibers, fibers (e.g., Kevlar), orother polymeric elements (e.g., UHMWPE). Such elements may createregions of increased tensile strength, elongation resistance (butkeeping flexibility) or areas of stiffness complemented by areas offlexibility. The specific angular position of the tensile or stiffeningelement(s) may vary along the length to create complex bend profiles, orcomplex support profiles, etc. For example, as shown in FIG. 7B, threetensile elements 445 are provided that are located about one hundredtwenty degrees) (120° from each other about the circumference of theapparatus 410. In the longitudinal configuration (e.g., with thedispenser(s) at the A1 location), the apparatus 410 may be substantiallyinflexible in all planes, while in another region, the stiffness may betransitioned such that the resulting stiffness resists motion except inone plane.

The foregoing disclosure of the exemplary embodiments has been presentedfor purposes of illustration and description. It is not intended to beexhaustive or to limit the invention to the precise forms disclosed.Many variations and modifications of the embodiments described hereinwill be apparent to one of ordinary skill in the art in light of theabove disclosure.

Further, in describing representative embodiments, the specification mayhave presented the method and/or process as a particular sequence ofsteps. However, to the extent that the method or process does not relyon the particular order of steps set forth herein, the method or processshould not be limited to the particular sequence of steps described. Asone of ordinary skill in the art would appreciate, other sequences ofsteps may be possible. Therefore, the particular order of the steps setforth in the specification should not be construed as limitations on theclaims.

While the invention is susceptible to various modifications, andalternative forms, specific examples thereof have been shown in thedrawings and are herein described in detail. It should be understood,however, that the invention is not to be limited to the particular formsor methods disclosed, but to the contrary, the invention is to cover allmodifications, equivalents and alternatives falling within the scope ofthe appended claims.

1. A method for making a tubular body, comprising: directing a primarymandrel along a central axis of a braiding apparatus such that theprimary mandrel is surrounded by a plurality of reinforcement carryingelements in a predetermined configuration relative to the central axis;providing an elongate conductor dispenser at a first location adjacentto the reinforcement carrying elements and offset from the central axis;with a conductor feeding from the dispenser at the first location,simultaneously wrapping reinforcement members from the reinforcementcarrying elements and wrapping the conductor from the dispenserhelically around a first portion of the primary mandrel; moving thedispenser to a second location; with the conductor feeding from thedispenser at the second location, wrapping reinforcement members fromthe reinforcement carrying elements helically around a second portion ofthe primary mandrel while the conductor extends substantially axiallyalong the second portion; applying an outer jacket around the primaryand secondary mandrels after wrapping the one or more reinforcementmembers therearound; and removing the primary mandrel to define aprimary lumen within the tubular body. 2-26. (canceled)
 27. A tubulardevice for a catheter or sheath comprising a proximal end and a distalend sized for introduction into a patient's body, the tubular devicecomprising: a central lumen extending between the proximal and distalends, thereby defining a longitudinal axis; an elongate conductorextending at least partially between the proximal and distal endsadjacent the central lumen; one or more reinforcement members comprisingwindings extending helically around the central lumen between theproximal and distal ends; and an outer jacket surrounding the one ormore reinforcement members, wherein the tubular device comprises a firstportion in which the conductor extends helically around the centrallumen, and a second portion in which the conductor extends substantiallyparallel to the longitudinal axis and either a) all of the windingssurround the central lumen and the conductor remains outside thewindings, b) at least some of the windings pass between the centrallumen and the conductor and at least some of the windings surround boththe central lumen and the conductor, and c) all of the windings surroundboth the central lumen and the conductor.
 28. The tubular device ofclaim 27, wherein the second portion is a distal portion adjacent thedistal end, and the first portion is an intermediate portion between theproximal end and the distal portion.
 29. The tubular device of claim 28,further comprising one or more sensing elements carried on the distalportion and coupled to the conductor.
 30. The tubular device of claim28, wherein the conductor comprises a plurality of wires, the tubulardevice further comprising a plurality of sensing elements carried on thedistal portion and coupled to respective wires of the plurality ofwires.
 31. The tubular device of claim 28, wherein the plurality ofwires are braided around the central lumen in the same directionimmediately adjacent one another along the first portion.
 32. Thetubular device of claim 28, further comprising a steering elementextending between the proximal and distal ends, the steering elementextending along the distal portion within an auxiliary lumen, theauxiliary lumen extending substantially parallel to the longitudinalaxis along the distal portion offset about ninety degrees around acircumference of the distal portion relative to the conductor.
 33. Thetubular device of claim 27, wherein the conductor exits through theouter jacket at a location adjacent the second portion.
 34. The tubulardevice of claim 33, wherein the second portion comprises a proximalportion adjacent the proximal end, the tubular device further comprisinga handle on the proximal end including a connector, wherein theconductor is coupled to the connector.
 35. The tubular device of claim27, wherein the tubular device further comprises a third portionadjacent the second portion in which the conductor extends helicallyaround the central lumen.
 36. The tubular device of claim 27, whereinthe tubular device further comprises a third portion adjacent the firstportion opposite the second portion in which the conductor extendssubstantially parallel to the longitudinal axis and either a) all of thewindings surround the central lumen and the conductor remains outsidethe windings, b) at least some of the windings pass between the centrallumen and the conductor and at least some of the windings surround boththe central lumen and the conductor, and c) all of the windings surroundboth the central lumen and the conductor.
 37. The tubular device ofclaim 27, wherein the conductor comprises a plurality of wires that arebraided around the central lumen in the same direction immediatelyadjacent one another along the first portion.
 38. The tubular device ofclaim 27, wherein the wires exit through the outer jacket adjacent thesecond portion. 39-46. (canceled)
 47. A tubular device for a catheter orsheath comprising a proximal end and a distal end sized for introductioninto a patient's body, the tubular device comprising: a central lumenextending between the proximal and distal ends, thereby defining alongitudinal axis; one or more reinforcement members comprising windingsextending helically around the central lumen between the proximal anddistal ends; an outer jacket surrounding the one or more reinforcementmembers; and a plurality of conductors extending at least partiallybetween the proximal and distal ends adjacent the central lumen; whereinthe tubular device comprises a distal portion adjacent the distal endcomprising a plurality of sensing elements spaced apart from one anotheralong the distal portion, each sensing element coupled to at least oneof the conductors, and wherein the tubular device comprises anintermediate portion proximal to the distal portion in which theconductors extend helically around the central lumen and are braidedwith the reinforcement members.
 48. The tubular device of claim 47,wherein the conductors exit through the outer jacket at a locationadjacent the proximal end.
 49. The tubular device of claim 48, furthercomprising a handle on the proximal end including one or moreconnectors, wherein the conductors are coupled to the one or moreconnectors.
 50. The tubular device of claim 48, wherein the conductorsexit through the outer jacket at the same axial location within thehandle.
 51. The tubular device of claim 47, wherein the conductors exitthrough the outer jacket at different axial locations adjacent theproximal end.